Service Line Lead – NAM Regulatory Development & Sciences Job at Product Life Group

Job Description

ProductLife Group is a global consulting and outsourcing partner to the life sciences industry. We support pharmaceutical and biotechnology companies across the full product lifecycle, from early development through post-marketing activities. We are seeking a Service Line Lead – NAM Regulatory Development & Sciences to hold full accountability for the performance, delivery, and growth of PLG’s Regulatory Affairs Service Line in North America.

Job Responsibility

Own end-to-end performance and delivery of the Regulatory Development & Sciences Service Line
Drive service line KPIs including quality, timeliness, utilization, revenue, margin, and client satisfaction
Ensure consistent application of global standards, methodologies, SOPs, and quality requirements across all engagements
Act as senior escalation point for clients, balancing delivery quality, commercial objectives, and client expectations
Lead development and execution of global regulatory strategies across all stages of development, from pre‑IND to post‑marketing
Act as senior regulatory SME for complex and high‑impact programs
Serve as on‑demand Head / VP / Director of Regulatory Affairs for client organizations
Lead Health Authority interactions, including acting as Authorized Sponsor Representative when required
Provide strategic oversight and hands-on input into Health Authority meeting packages, special designation requests, and major regulatory submissions
Own financial and commercial management of the Service Line, including forecasting, budgeting, revenue planning, margin protection, and utilization
Partner closely with Commercial teams to support sales calls, proposals, scoping, pricing input, and bid defenses
Support sustainable growth of the service line through disciplined commercial decision-making
Lead capacity planning, resource allocation, and talent deployment in collaboration with staffing and operations
Lead, mentor, and develop senior regulatory professionals in a matrix consulting environment
Support performance management, engagement, succession planning, and retention
Contribute to evolution of service offerings, process improvements, and approved capability roadmaps
Represent the Service Line in internal governance forums and selected external or industry-facing engagements.

Requirements

Bachelor’s degree in a scientific discipline (life sciences, pharmacy, biology, chemistry, or related field)
Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred
20+ years of experience in regulatory affairs within the biotechnology and/or pharmaceutical industry
Demonstrated experience leading regulatory strategy and execution across early- and late-stage development through marketing authorization
Proven leadership experience in a consulting, professional services, or matrixed delivery environment
Extensive experience interacting with U.S. and ex‑U.S. Health Authorities and interpreting global regulatory frameworks
Deep expertise in global regulatory requirements, guidance, and legislation applicable to drug and biologic development
Ability to translate regulatory requirements into practical, executable development and submission strategies
Advanced understanding of regulatory submission strategy, Health Authority engagement, and regulatory risk management
Strong financial and operational acumen, including KPI management, forecasting, budgets, and utilization within consulting environments.

Product Life Group - All Job Offers

Select Country

Service Line Lead – NAM Regulatory Development & Sciences

Job Description

Job Responsibility

Requirements

Looking for more opportunities?

Service Line Lead – NAM Regulatory Development & Sciences

Senior Analyst - OTC

Senior FP&A Analyst (Expense & Headcount Focus)

Java Back-End Engineer

Business Application Consultant

Kitchen staff

SOC Analyst

Kitchen Staff

Lead Business Intelligence Product Owner

Our AI answers in your language